The Protocol Review and Monitoring System (PRMS) ofthe University of California Davis Cancer Center (UCDCC) provides a mechanism for ensuring internal oversight ofthe scientific and research aspects of cancer clinical trials and for assuring that the UCDCC's clinical resources are engaged in the most optimal way. A key element of the PRMS is the Scientific Review Committee (SRC) which provides internal peer review and approval of new treatment and prevention research trials prior to submission to the Institutional Review Board (IRB), which focuses on the protection of human subjects. SRC provides essential review elements for scientific merit, prioritization, resource allocation and accrual monitoring. The PRMS is intended to cover clinical research activity meeting the NCI definition of a clinical trial, as defined in the Data and Safety Monitoring Plan (DSMP) of this application (described further in a separate narrative).